Vertex on Road to FDA Approval for Hepatitis C Virus Drug
Congratulations to Cambridge biotech company, Vertex Pharmaceuticals, Inc., for getting one step closer to FDA approval for telaprevir, its experimental drug to treat the hepatits C virus—a viral disease that leads to inflammation of the liver. Yesterday, an FDA medical advisory committee—an independent panel of medical experts from across the country— unanimously recommended that the drug be approved when the FDA makes it decision which is scheduled to occur by May 23. The FDA typically follows the panel’s advice.
According to an article in the Boston Globe, if approved, this would be the first blockbuster drug (drugs with more than $1 billion in annual revenues) launched by a Massachusetts company in almost a decade and Vertex’s first drug commercialized solely by the company in its 22-year history. Vertex has been working on this treatment for the liver-ravaging disease since 1993. Quiz for Early Diagnosis of Autism in Infants The Wall Street Journal reports on a study conducted at the University of California, San Diego’s Autism Center of Excellence, that showed that a screening in a pediatrician’s office can detect autism-like symptoms in children as young as 12 months old. Autism typically appears during the first three years of life and affects a person’s ability to communicate and interact with others. The 5-minute questionnaire asks parents to identify potential problems in language and communications skills. Early diagnosis and treatment of autism—which according to the Autism Society affects 1.5 million Americans—are thought to improve outcomes. While the study did flag some babies who turned out to be developing normally, the study found that the benefits of the test outweighed the downsides. Typically, children are not diagnosed until age 2 or 3 when symptoms like lack of eye contact become more obvious. The study found that of the nearly 10,500 infants screened, 184 scored lower than expected and were referred for further evaluation and tracked up to three years. 32 infants were diagnosed with an autism-spectrum disorder and 101 infants were found to have a language or developmental delay. This is the first and only study that demonstrated the feasibility of using a broad screening measure in a medical setting.
Think Twice about Petting an Armadillo
Using genetic sequencing, researchers have found that armadillos are a likely source of leprosy among some Americans who have contracted the disease in the U.S. According to an article in The Wall Street Journal, researchers found that infected armadillos captured in five southern states have the same strain of the agent that causes leprosy as that found in patients from southern states diagnosed with the disease. The strains are genetically identical, providing a biological link between the infection that occurs in human beings and those that occur in animals. The study was sponsored by the National Institute of Allergy and Infectious Diseases and published in the New England Journal of Medicine.
While leprosy is rare in the U.S. with fewer than 250 new cases reported each year and most cases are acquired overseas, one-third of patients were not out of the country or couldn’t recall contact with another infected person. The study could prompt doctors encountering patients with unexplained skin lesions to ask whether they have handled armadillos.
For the first time in 27 years, the National Institute on Aging and the Alzheimer’s Association have updated clinical diagnostic criteria for Alzheimer’s disease to focus on earlier stages of the disease and as it gradually changes over many years. The original criteria only focused on later stages, when symptoms of dementia are already evident. The updated guidelines now focus on the earliest preclinical stages, mild cognitive impairment and dementia. Most notably, the guidelines report on the use of imaging and biomarkers in blood and spinal fluid that may help determine whether any changes are due to Alzheimer’s. While this marks a major change in how experts study Alzheimer’s disease, these tests are to be only used for research, and not for diagnosing Alzheimer's in the general public. The new guidelines are published in the most recent issue of Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association.
On April 8th, ModernHealthcare.com reported that Dr. Farzad Mostashari was selected as the next head of the Office of the National Coordinator for Health Information Technology at Health and Human Services. Members of the healthcare community are applauding the selection of Mostashari as Dr. David Blumenthal’s successor.
In a statement released by the Healthcare Information and Management Systems Society on April 8th, HIMSS recognized “Dr. Mostashari’s leadership on a number of issues, including provider adoption and associated certification requirements, interoperability and health information exchange, and efforts to engage all communities in driving the innovation that is necessary for transforming healthcare, and we are very comfortable with the directions he advocates.”
Soon after his new appointment, Mostashari took to outlining his goals and expectations on April 13th at a meeting of the federally chartered Health IT Policy Committee, which he chairs. Mostashari pledged to continue to run a transparent office but that he would “double down” on efforts to improve communication and focus the ONC’s energy on improving care coordination.
Under Mostashari, he says the ONC will continue to "work with the market and tap into the energy of the private sector while we continue to make a more perfect market. And while we do that we have to continue to look out for the little guy."
According to Mostashari, there are three areas that require increased attention. The first includes "boots on the ground." He said that, as a country, “we're moving into an intense implementation and execution phase.” Something that Mostashari knows to be difficult from personal experience implementing electronic health record systems in New York, where he served as a public health official.
The second area of importance is the goal to implement a patient-centric healthcare system, “the concept of putting the patient at the center of everything we do,” said Mostashari. He plans to direct the ONC to exert significant effort and focus on patient privacy and security. He says, “we owe that to the American people and also in terms of making progress on ways we can technologically have opportunities for greater patient protection."
The final area of focus is the meaningful use initiative. Mostashari said "everything we've done in meaningful use has not been about the technology but about improving quality of care. Quite consciously, we need to be aligning and coordinating our work in the service of the broader national health goals."
The Schwartz Healthcare IT Practice is interested to see what Mostashari will accomplish in his new position. Will he hit his target of implementing a completely patient-centric healthcare system? Will the ONC be a transparent organization?
What do you think about Mostashari as the selection as the head of the ONC? Sound off in the comments section below, or tweet your thoughts to the Schwartz Healthcare IT Practice Group @SchwartzPRx.
Medication Errors at Hospital Continue to Rise The number of people treated in hospitals in the U.S. for medication error related problems has increased by 50 percent in recent years. An article in the New York Times reports that 1.9 million people became ill or injured from medication side effects or because they took or were given the wrong type or dose of medication, compared with 1.2 million injured in 2004, according to the Agency for Healthcare Research and Quality (AHRQ).
The cost of medication mistakes is the most common cause of medical errors, resulting in an estimated $3.5 billion in added costs for lost wages, productivity and additional health care expenses, according to a 2006 report issued by the Institute of Medicine. The authors of the report outlined a series of recommendations for patients, healthcare organizations, government agencies and pharmaceutical companies to curtail medication errors. These actions including the creation of new, consumer-friendly resources for patients to receive drug information as well as the call to action for all prescriptions to be written electronically by 2010.
While there has been an increased awareness about the dangers of medication errors, these numbers illustrate that this continues to be a problem.
Are you a Short Sleeper?
As someone who gets grumpy when sleep-deprived and loves a good nap, my curiosity was piqued by the Wall Street Journal article, “The Sleepless Elite,” which examined why some people are totally fine after a few hours of sleep and seem to get so much done throughout the day. For this small group of people – estimated at just 1 to 3 percent of the population - and known as “short sleepers,” they typically go to bed way past midnight and get up a few hours later, without the need for naps or caffeine.
While there are not a lot of studies published about what makes someone a short sleeper, a gene variation common to two short sleepers was discovered in 2009. Scientists were able to replicate the gene variation in a strain of mice and found that these mice needed less sleep than usual, too. Researchers are currently recruiting more candidates and hope to find more gene variations they have in common. Interestingly, the 20 short sleepers involved in the study share common characteristics. Their circadian rhythms are different from most people, are typically very upbeat and have high metabolism .They also seem to have a high tolerance for physical pain and psychological setbacks. MS Study Looks at Blocked Veins A study conducted by researchers at the State University of New York at Buffalo looked at the whether vein blockages in the neck can cause multiple-sclerosis as traditionally thought. Many patients with MS turn to risky surgery to unblock the veins in their neck when they fail to respond to drug treatments. As reported in the Wall Street Journal, while the study found a relationship between MS and blocked veins, it concluded that this may be a consequence rather than a cause of MS. The research is to be presented at the upcoming American Academy of Neurology meeting in Honolulu.
Healthcare marketers are in a bit of a quandary on how to effectively use social media. Draft guidance from FDA has been delayed once again and while this has been an issue for some medical device marketers others are successfully engaging in social media practices. There are also some who are not convinced social media is worthwhile. What do you think?
Are you listening? Engaging? Dipping your toes in?
Here’s your opportunity to opine. The Massachusetts Medical Device Industry Council (MassMEDIC), the voluntary grassroots association of medical device manufacturers and associated companies in the Commonwealth, is conducting a survey to solicit feedback on social media usage. Click on the link above to weigh in. We'd love to hear from you.
If you are curious to know what others are doing, Jim Weinrebe, an EVP and co-leader of our healthcare PR practice at Schwartz, will be sharing the survey results at a MassMEDIC program on the "Use of Social Media During Regulatory Uncertainty" on Friday, May 13. Jim will be joined by David Harlow, lawyer and author of HealthBlawg and Jacqueline Klosek, senior counsel at Goodwin Proctor. Mary Murray with Hamilton Brook Smith Reynolds will be moderating.
Following are a few notable updates from Schwartz Communications’ Healthcare IT practice. We intend to bring you these updates – which spotlight representative clients in our practice group – on a periodic basis going forward.
First up, a big congrats to Online Care provider American Well, who were awarded Gold in the “Innovative Services: Health, Wellness & Safety” category at the annual Edison Awards gala in New York City. Presented by the Discovery Channel, the Edison Awards recognizes innovation and excellence in the development, marketing and launch of new products and services. Gold winners in other categories include Apple’s iPad and the Chevy Volt electric car. Not bad company!
Kudos are also in order for WellDoc, who were named a Silver finalist for the 2011 SABRE awards, presented by The Holmes Report, the leading publication for the PR industry. The campaign “WellDoc and mHealth are Here to Stay” was submitted by the Schwartz team for this prestigious national awards competition, which will be presented on May 10 at New York’s Cipriani 42nd Street.
Schwartz had another successful HIMSS show, which attracted roughly 31,000 healthcare IT professionals to Orlando. Highlights included the launch of a Schwartz YouTube channel featuring on-site interviews, daily show recaps and spotlight videos on many of our attending clients, including NaviNet, Phytel, DiagnosisOne and Omincell.
With literally hundreds of EMR vendors in the HCIT space - and more emerging each year - it’s tough for marketers and public relations pros to differentiate a company’s Electronic Medical Record (EMR) offering from any of the others. But some do, including Schwartz client NaviNet. The healthcare communications company launched an EMR and Practice Management (PM) solution in late 2010 and Schwartz used HIMSS as a venue to brief nearly a dozen reporters on NaviNet EMR, NaviNet PM and other mobile clinical product offerings. Steve Campbell of EMR Daily News wrote a great piece titled “Is NaviNet Poised to Become a Player in the EMR Space?,” concluding that “Having 50% of the physicians in the country already using and trusting NaviNet to interact with insurance companies on a daily basis will certainly simplify the process of introducing these new products and services.”
DiagnosisOne used HIMSS to demo their suite of products, including order sets, clinical decision support, analytics, and public health reporting. Check out CEO Mansoor Khan’s byline on tying compensation to physician performance in Executive Insight magazine and the company’s new white paper “Clinical IT requirements for ACOs: Enabling Effective Patient & Population Management.” The topic is especially timely as new ACO rules were recently announced. DiagnosisOne is delighted CMS has gotten many things right in the rules. See what Mansoor has to say about them and what’s ahead for ACOS in the company’s blog.
Omnicell, Inc., leading provider of medication and supply chain management solutions to healthcare facilities, demonstrated its interoperable, standards-based solutions at the HIMSS11 Interoperability Showcase. This was the first time automated dispensing cabinets was featured in the pharmacy domain area of the Showcase.
The GE Healthcare team also had another successful year at HIMSS, briefing 40+ media outlets and securing more than 60 articles featuring GE Healthcare innovations. The Schwartz team hosted a “tweetup” at the show, encouraging use of the “GEtweetup” hashtag, which resulted in 61 tweets reaching more than 128,000 followers. The team also used HIMSS to launch two mobile applications, securing on-message coverage tied to the larger industry discussion about the adoption of mobile apps and their benefits to physicians and patients. Coverage appeared in Healthcare Informatics, EMR and EHR, Executive Insight, and FierceHealthIT among many others.
Finally, Schwartz welcomed iNTERFACEWARE, a provider of software that allows companies to easily manage the exchange of electronic healthcare data, and Circadence, which develops solutions that improve the performance of company computer networks as new Healthcare IT clients. We look forward to bringing you more updates on our Healthcare IT practice!
When your physician pulls out an iPad during your office visit, instead of assuming she is checking her Facebook profile or sending a text to a friend, rest assured she is doing it on your behalf. Reports have shown that physicians are increasingly relying on the Apple iPad to help treat their patients. Physicians are also facing increasing numbers of patients with limited time to spend with each. They need the most efficient way to access the most recent and critical medical information and make informed clinical decisions to form the best treatment plan.
An iPad or mobile device offers a potentially life-saving tool at their fingertips to ensure patients receive the best care in the shortest amount of time. Having readily accessible and updated clinical data on the clinician’s iPad or mobile device when treating patients can have a direct impact on the quality of patient care.
According to a recent Chilmark Research report, an estimated 20% of U.S. physicians were using the iPad by the end of 2010. And with the recent launch of the Apple iPad 2, the trend is only expected to continue. Physicians and healthcare professionals find the large screen and high quality graphics of the iPad easy to use when treating patients, and much easier to transport than a laptop. Health providers use medical iPad apps, such as those from Schwartz client Epocrates, a clinical database of drugs and clinical data that identifies medication interactions and pill pictures to minimize harmful medication errors, or another Schwartz client, GE Healthcare, which collaborated with AirStrip to provide an app that will allow doctors (including Cedars-Sinai physicians) to view near real-time cardiac EKG information on iPhones and iPads. One of public health’s biggest challenges — chronic disease management — becomes easier on the iPad with clinicians communicating with diabetes patients through mobile technology to improve medication adherence in response to real-time blood glucose patient data with WellDoc, another Schwartz client.
As physicians nervously await the upcoming deadlines to achieve ‘meaningful use of health IT’ through the implementation of electronic medical records, the possibility of an iPad electronic health record is very appealing as doctors find most medical iPad apps easy to install and use. Both GE Healthcare and Epocrates are expanding their solutions to clinicians by launching iPad-specific electronic medical records soon to help doctors move their practice into the high-tech age.
So the next time your physician pulls out an iPad, feel confident in that she wants to make sure she is making the best medical decisions for your benefit without having to flip through a heavy reference hardcover book to look up information that may be outdated. And only challenge her to a game of Angry Birds on the iPad when the office visit is over!
No Link Between Foods with Artificial Coloring and Hyperactivity
An expert panel convened by the FDA has determined that there is no proof that foods with artificial colorings cause hyperactivity in children and there is no need for these foods to carry special warning labels. According to the New York Times article, artificial color which is found in children’s favorites like Froot Loops, Life Savers and Hostess Twinkies have, have been in debate since the 1970s when a pediatric allergist successfully treated hyperactivity in some children by prescribing a diet that included eliminating foods with artificial coloring.
The panel was conveyed after FDA scientists decided that children with behavioral problems may see their symptoms worsen by eating foods with synthetic color additives. The panel voted 8 to 6 that a warning on food with artificial colors was not needed but did say more studies needed to be conducted. Lung Cancer Death Rates Improve for Women For the first time in 40 years, lung cancer death rates for women fell along with a continued decline in the overall cancer deJath rate. The report, published online in the Journal of the National Cancer Institute, showed that lung cancer death rates among women dropped nearly 1 percent yearly between 1992 to 2007.
Researchers with the U.S. National Cancer Institute, the North American Association of Central Cancer Registries, the U.S. Centers for Disease Control and Prevention, and the American Cancer Society compiled the report, which provides an analysis of long- and shorter-term trends in cancer incidence and death rates. The report focuses on the 15 most common cancers and the 15 most common cancer-related causes of death in men and women.
The report found an 0.8 percent decline in new cancer diagnoses every year between 2003 and 2007, and an annual decline in death rates of 1.6 percent. Researchers did find that the incidence of childhood cancer rose slightly during this time period and the decline that started in the mid-1970s in treating childhood leukemia has slowed. One of the reasons for the slowing decline is that the newer, targeted cancer therapies are only studied and approved in adults.
Yesterday, HHS Secretary Kathleen Sebelius and CMS Administrator Don Berwick held a much anticipated con call to announce proposed rules on the formation of Accountable Care Organizations, or ACOs. Sometimes referred to as the “unicorn” of health reform (everybody’s heard of it, nobody’s seen one), ACOs refer to a new model for healthcare organizations that creates integrated networks of physicians and hospitals that will each be its own enterprise, sharing responsibility for caring for a population of patients. The goal is to provide coordinated care that will result in improved quality of care, better outcomes and cost savings. According to the HHS, ACOs could save Medicare up to $960 million in its first three years.
As Dr. Berwick explained, “An ACO will be rewarded for providing better care and investing in bettering the health and lives of patients. ACOs are not just a new way to pay for care. They are a new model for the organization and delivery of care. [ACOs] are designed to lift the burden of fragmented and disconnected care from patients, while improving the partnership among patients, doctors, hospitals and other providers of care in making health care decisions.”
Still open to a 60-day public review cycle and possible change, the rules go into effect in January 2012, and are aimed at partnerships of primary care doctors, specialists and hospitals providing care to 5,000 or more Medicare beneficiaries over a period of three or more years. (In theory, ACOs could be a model for the entire healthcare system). A brisk 429-page read, the proposed rules outline 65 quality measures (pgs. 174-194) that ACOs must meet in five key quality “domains”: • Patient/caregiver care experiences • Care coordination • Patient safety • Preventative health • At-risk population/frail elderly health
They also outline how financial incentives would work. ACOs would be bonused on meeting government-set quality goals and financial savings (against a calculation of how much a Medicare patient should “cost”) while also sharing in the risk if they do not meet targets. Berwick summarizes that there will be two “shared responsibility” options for ACOs: “In the first model, ACOs earlier in their evolution can elect to assume a smaller share of upside gains but no risk of loss for 2 years and then transition in year 3 to accepting risk. In the second model, organizations that are willing to take on both upside gains and downside risk can qualify for a higher proportion of shared savings from the start.”
Many Schwartz Communications clients stand to benefit from the successful adoption of the ACO model and are eagerly awaiting further details. These are companies that have promising IT-based solutions for population health management, clinical decision support, care coordination, preventative health and wellness, chronic care management, health information exchange and analytics – all areas that are at the heart of the ACO concept. They represent a microcosm of the healthcare IT industry at large. However things turn out with ACOs, one thing is clear, transforming healthcare to be more patient-centered, cost-efficient, coordinated and based on outcomes (versus procedures) will be a great step in the right direction toward meaningful reform.
Here’s your opportunity to opine. The 
